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NCT ID: NCT06115655 Recruiting - Bile Duct Diseases Clinical Trials

A Single-center, Prospective Cohort Study on the Differentiation of Benign and Malignant Bile Duct Stenosis Based on Bile and Peripheral Blood cfDNA Methylation Profiles

Start date: October 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to detect the methylation characteristics of cfDNA in the bile and plasma of patients with bile duct stricture. The main question it aims to answer is: Can the developed model, using peripheral blood and bile cell-free DNA sequencing, work well in screening and classifying unknown biliary stricture? Participants will collect approximately 10ml of peripheral blood and 5ml of bile from the patient.

NCT ID: NCT06115642 Recruiting - Clinical trials for Advanced Solid Tumor

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors

Start date: November 28, 2023
Phase: Phase 1
Study type: Interventional

This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX43.

NCT ID: NCT06115512 Recruiting - Clinical trials for Degenerative Disc Disease

A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion

Start date: December 8, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the overall efficacy of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion.

NCT ID: NCT06115070 Recruiting - Thrombosis Clinical Trials

ALteplase in Patients With LOW NIHSS and Specified Disabling Deficits

ALLOW
Start date: November 17, 2023
Phase: Phase 4
Study type: Interventional

About 1/3 patients with mild stroke have poor prognosis, whether patients with this type undergo thrombolysis has been a controversial issue. A pooled analysis published in the Lancet in 2014 included 9 high-quality RCT studies of intravenous thrombolysis such as NINDS and IST3, and a total of 666 (10%) patients with mild stroke were included in the analysis. For mild stroke, the proportion of good prognosis in the control group and the alteplase group was 58.9% and 68.7% (OR 1.48, 95%Cl 1.07-2.06), respectively. Therefore, guidelines recommended alteplase thrombolytic therapy for patients with mild stroke. However, PRISMS, a randomized controlled trial of intravenous thrombolytic therapy for mild stroke published in 2018, found that alteplase intravenous thrombolytic therapy did not improve clinical outcomes compared with aspirin in patients with mild non-disabled stroke (90-day mRS 0-1 ratio 78.2% vs 81.5%), and the incidence of symptomatic intracranial hemorrhage was higher. However, a major limitation of the PRISMS study was that more than 85% of patients had numbness and dysarticulation, so this conclusion cannot be extrapolated to patients with other mild stroke symptoms. Moreover, due to the early termination of the sponsorship of this trial, the number of enrolled cases did not reach the pre-designed number, resulting in a serious decline in the authenticity of the study results. Symptoms and outcomes of minor stroke are important criteria for assessment. However, there is currently no uniform standard for the assessment of disability. Therefore, the center developed a mild stroke EMSS assessment scale to refine the disability assessment of stroke symptoms. It was found that intravenous thrombolytic therapy was safe and effective for patients with symptoms such as dizziness, disorientation, memory impairment, decreased muscle strength at the proximal end of one limb, and ataxia while standing. Therefore, the purpose of this study was to investigate whether ischemic stroke patients with onset or detection time within 4.5 hours, and mild stroke patients with NIHSS score ≤5 with any of the following symptoms: dizziness, disorientation, memory impairment, single proximal muscle strength decline, or ataxia while standing could benefit from intravenous thrombolysis based on CT/MRI screening in the Chinese population.

NCT ID: NCT06114953 Recruiting - Clinical trials for Kidney Transplant Immunosuppression

Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients

Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

This prospective, randomized controlled study is intended to enroll 152 patients in the early stages of donor kidney transplantation at six clinical centers in China between January 2023 and January 2024. All patients meeting the inclusion criteria were randomly assigned 1:1 to either Mizoribine or Mycophenolate Mofetil for 12 months. At the baseline of follow-up (before enrollment) and each follow-up point, all clinical indicators of patients were recorded to measure the therapeutic effect.

NCT ID: NCT06114940 Recruiting - Neoplasms Clinical Trials

Neoadjuvant Immune-based Combinations in Patients Undergoing Nephrectomy for Locally Advanced ccRCC

Start date: December 20, 2022
Phase: Phase 2
Study type: Interventional

The objective of this single-center clinical trial was to evaluate the objective response rate and safety of Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib) in neoadjuvant treatment of(T2a-T4NanyM0 or TanyN1M0) clear cell renal cell carcinoma.

NCT ID: NCT06114784 Recruiting - Severe Pneumonia Clinical Trials

Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter, Cohort Study

MASS
Start date: September 25, 2023
Phase:
Study type: Observational

This study was a prospective multicenter cohort of severe pneumonia. And by collecting clinical samples to clarify the correlation between lung microbiome, intestinal microbiome, host susceptibility, and prognosis of severe pneumonia patients.

NCT ID: NCT06114511 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer

Start date: April 24, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of injectable BL-M07D1 in patients with HER2-mutated, locally advanced or metastatic non-small cell lung cancer.

NCT ID: NCT06114420 Recruiting - Clinical trials for Locally Recurrent Colorectal Cancer

Surgical Treatment and Molecular Marker Exploration of Locally Recurrent Colorectal Cancer

Start date: January 30, 2023
Phase:
Study type: Observational

This study intends to explore the clinicopathological characteristics and survival prognosis of locally recurrent colorectal cancer patients with different treatment modes by retrospectively analyzing the medical records of locally recurrent colorectal cancer patients who received hospitalization in our center. Transcriptome sequencing and public databases were used to screen for molecular markers related to locally recurrent colorectal cancer and to explore molecular markers' regulatory role in the progression of locally recurrent colorectal cancer.

NCT ID: NCT06114329 Recruiting - Fabry Disease Clinical Trials

Study of the Safety and Biologic Activity of AL01211 in Treatment Naive Males With Classic Fabry Disease

Start date: October 25, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label study designed to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of AL01211 in male subjects with classic Fabry disease who have never received any treatment (eg. ERT or chaperone therapy). Eligible subjects will receive 182 days (26 weeks) of study treatment as the primary study period followed by an extension period. The total study duration for a subject is up to at most 2 years including the primary period of 26 weeks.